NCT00543543 · OUTCOME

Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Predose 4

Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) · Source last updated 2018-11-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: GEOMETRIC_MEAN
Unit: milli Merck U/mL
Interval / dispersion: 95% Confidence Interval
Time frame: Month 60: predose 4 in the Extension Study (Cohort 1)

What was measured

Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. This outcome measure applied to Cohort 1 participants only.

Analysis population: All participants in Cohort 1 who received all 3 vaccinations of mid-dose V503 in the Base Study, were seronegative at Day 1 and PCR negative from Day 1 to Month 7 for the relevant HPV types, had no other violation that could interfere with evaluation of immune response, and provided post-dose 4 serum.

Groups in this outcome

Extension Study: Mid-dose V503 (Cohort 1)

V503 mid-dose 0.5 mL injection in a 3-dose regimen in the Base Study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Extension Study: Mid-dose V503 (Cohort 1)	150

Reported measurements

Anti-HPV Type 6 (n=101)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	143.1	Not reported	117.9	173.7	Not reported

Anti-HPV Type 11 (n=112)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	82.9	Not reported	68.1	100.9	Not reported

Anti-HPV Type 16 (n=128)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	324.4	Not reported	266.7	394.7	Not reported

Anti-HPV Type 18 (n=142)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	62.5	Not reported	49.5	78.9	Not reported

Anti-HPV Type 31 (n=135)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	69.2	Not reported	56.6	84.4	Not reported

Anti-HPV Type 33 (n=141)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	44.7	Not reported	37.0	54.1	Not reported

Anti-HPV Type 45 (n=148)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	20.8	Not reported	17.0	25.5	Not reported

Anti-HPV Type 52 (n=134)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	33.7	Not reported	27.6	41.1	Not reported

Anti-HPV Type 58 (n=132)

Values in milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Extension Study: Mid-dose V503 (Cohort 1)	50.9	Not reported	40.9	63.3	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
117.9
upper Limit
173.7
value
143.1
title
Anti-HPV Type 6 (n=101)
categories
measurements
group Id
OG000
lower Limit
68.1
upper Limit
100.9
value
82.9
title
Anti-HPV Type 11 (n=112)
categories
measurements
group Id
OG000
lower Limit
266.7
upper Limit
394.7
value
324.4
title
Anti-HPV Type 16 (n=128)
categories
measurements
group Id
OG000
lower Limit
49.5
upper Limit
78.9
value
62.5
title
Anti-HPV Type 18 (n=142)
categories
measurements
group Id
OG000
lower Limit
56.6
upper Limit
84.4
value
69.2
title
Anti-HPV Type 31 (n=135)
categories
measurements
group Id
OG000
lower Limit
37.0
upper Limit
54.1
value
44.7
title
Anti-HPV Type 33 (n=141)
categories
measurements
group Id
OG000
lower Limit
17.0
upper Limit
25.5
value
20.8
title
Anti-HPV Type 45 (n=148)
categories
measurements
group Id
OG000
lower Limit
27.6
upper Limit
41.1
value
33.7
title
Anti-HPV Type 52 (n=134)
categories
measurements
group Id
OG000
lower Limit
40.9
upper Limit
63.3
value
50.9
title
Anti-HPV Type 58 (n=132)

denoms

counts
group Id
OG000
value
150
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
V503 mid-dose 0.5 mL injection in a 3-dose regimen in the Base Study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
id
OG000
title
Extension Study: Mid-dose V503 (Cohort 1)

param Type

GEOMETRIC_MEAN

population Description

All participants in Cohort 1 who received all 3 vaccinations of mid-dose V503 in the Base Study, were seronegative at Day 1 and PCR negative from Day 1 to Month 7 for the relevant HPV types, had no other violation that could interfere with evaluation of immune response, and provided post-dose 4 serum.

reporting Status

POSTED

time Frame

Month 60: predose 4 in the Extension Study (Cohort 1)

title

Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Predose 4

type

OTHER_PRE_SPECIFIED

unit Of Measure

milli Merck U/mL

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Preserved source evidence · Not medical advice